U.S. patent application number 14/181887 was filed with the patent office on 2015-08-20 for surgical alignment system, apparatus and method of use.
This patent application is currently assigned to OrthoGrid Systems, LLC. The applicant listed for this patent is Richard Boddington, Erik Noble Kubiak, Colin Edward Poole, Edouard Saget. Invention is credited to Richard Boddington, Erik Noble Kubiak, Colin Edward Poole, Edouard Saget.
Application Number | 20150230873 14/181887 |
Document ID | / |
Family ID | 47746795 |
Filed Date | 2015-08-20 |
United States Patent
Application |
20150230873 |
Kind Code |
A1 |
Kubiak; Erik Noble ; et
al. |
August 20, 2015 |
SURGICAL ALIGNMENT SYSTEM, APPARATUS AND METHOD OF USE
Abstract
A surgical positioning system is provided that includes a
radiolucent grid having a plurality of dimensioned radio-opaque
lines corresponding to surgical variables and a substrate connect
to or integral with the radiolucent grid. This system is used to
obtain subject specific data from an image of a subject obtained
during a surgical procedure by following the steps of: providing a
radiolucent grid having a plurality of dimensioned radio-opaque
lines relating to surgical variables; placing the subject on a
substrate; and obtaining subject specific data from an image of
said subject. This invention related to an apparatus made of a
radiolucent grid having a plurality of dimensioned radio-opaque
lines relating to surgical variables and a sealable radiolucent
container sized to receive the grid.
Inventors: |
Kubiak; Erik Noble; (Salt
Lake City, UT) ; Poole; Colin Edward; (Boise, ID)
; Boddington; Richard; (Austin, TX) ; Saget;
Edouard; (Boise, ID) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Kubiak; Erik Noble
Poole; Colin Edward
Boddington; Richard
Saget; Edouard |
Salt Lake City
Boise
Austin
Boise |
UT
ID
TX
ID |
US
US
US
US |
|
|
Assignee: |
OrthoGrid Systems, LLC
Boise
ID
|
Family ID: |
47746795 |
Appl. No.: |
14/181887 |
Filed: |
February 17, 2014 |
Current U.S.
Class: |
606/102 ;
378/205; 378/44; 427/2.11 |
Current CPC
Class: |
A61B 6/583 20130101;
A61B 6/58 20130101; A61B 6/505 20130101; A61B 6/4441 20130101; A61B
90/06 20160201; A61B 90/37 20160201; A61B 2090/067 20160201; A61B
6/485 20130101; A61B 90/50 20160201; A61B 6/487 20130101; A61B
2090/061 20160201; A61B 2090/376 20160201 |
International
Class: |
A61B 19/00 20060101
A61B019/00; A61B 6/00 20060101 A61B006/00 |
Claims
1. A surgical positioning system comprising: a radiolucent grid
having a plurality of dimensioned radio-opaque lines corresponding
to surgical variables and a substrate connect to or integral with
the radiolucent grid.
2. The system of claim 1 wherein the substrate is selected from the
group of: an operating room table mat, operating room table, a
mobile positioning device and a surgical drape.
3. The system of claim 1 wherein the substrate is an operating room
table mat and said grid is integrated into said operating room
table mat to form a dimensioned grid mat, said dimensioned grid mat
having at least one aperture in a top surface sized to accommodate
a positioning device, said positioning device sized to project
through and above said top surface of the dimensioned grid mat,
wherein the position of a subject on said mat can be maintained in
a selected position with said at least one positioning device.
4. The system of claim 3 further comprising an operating room table
with a top surface, wherein said grid is adjacent to said operating
room table top surface.
5. The system of claim 1 wherein the substrate is an operating room
table and said grid is integrated into said operating room table to
form a grid table assembly.
6. The system of claim 5, wherein the said operating room table mat
includes at least one aperture in a top surface sized to
accommodate a positioning device, said positioning device sized to
project through and above said top surface of the operating room
table mat, wherein the position of a subject on said surface of the
grid table assembly can be maintained in a selected position with
said at least one positioning device.
7. The system of claim 5, wherein the assembly further comprises at
least one internal positioning peg contacting the operating room
table and the operating room table mat to from a raised area
configured to stabilize a body part of the subject.
8. The system of claim 1 wherein the substrate is a mobile
positioning device and further comprises a leg holder device
configured to hold a subject's leg in place during surgery.
9. The system of claim 1 further comprising an apparatus to
facilitate the positioning of said grid relative to a subject,
wherein said grid comprises a plurality of support plates
configured to retain said grid, and wherein the apparatus to
facilitate the positioning of said grid is a medial-lateral slot in
said plate; and a central axis pin connected to at least one of
said plurality of support plates, wherein said medial-lateral slot
is configured to retain a central axis pin and to allow
medial-lateral translation of the grid plate relative to a
horizontal line of said support plates and to rotate around the
axis of said central axis pin wherein the medial-lateral slot is
comprised of a plurality countersunk grooves that are configured to
retain said central axis pin.
10. An apparatus comprising: a radiolucent grid having a plurality
of dimensioned radio-opaque lines relating to surgical variables
and a sealable radiolucent container sized to receive the grid.
11. The apparatus of claim 10 wherein said container is a C-arm
cover.
12. A method to obtain subject specific data from an image of a
subject obtained during a surgical procedure comprising: providing
a radiolucent grid having a plurality of dimensioned radio-opaque
lines corresponding to surgical variables and a substrate connect
to or integral with the radiolucent grid; placing the subject on a
substrate; and obtaining subject specific data from an image of
said subject.
13. The method of claim 12 wherein said wherein the data consists
of: a leg length, an off-set and a cup position; and further
comprising the step of adjusting the placement of a prosthetic
device during an arthroplasty based on the subject specific
data.
14. The method of claim 12 further comprising the steps of placing
the radiolucent grid having a plurality of dimensioned radio-opaque
lines relating to surgical variables in a sealable radiolucent
container sized to receive the grid to form a grid assembly; and
positioning said grid assembly over the C arm intensifier of an
X-ray machine.
15. The method of claim 12 wherein the data consists of: obtaining
of a "Y" axis corresponding to an anatomical axis of said subject
and an "X" axis corresponding to an angle related to an
abnormality, and further comprises the step of adjusting the
orthopedic abnormality based on the subject specific data.
16. The method of claim 12 wherein said "x" axis is selected from
the group consisting of: a proximal femoral angle, a lateral distal
femoral angle, a medial proximal fibular angle and a distal tibial
angle.
17. A method to print a radio-opaque grid pattern on a radiolucent
substrate comprising: printing a radio-opaque dimensioned grid
corresponding to surgical variables on a radiolucent substrate.
18. The method of claim 17 wherein the surgical variables are
selected for the group consisting of: specific reference angles,
length, positioning or targeting.
19. The method of claim 17 wherein said substrate is a surgical
drape.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This continuation-in-patent application claims the benefit
of U.S. provisional patent application Ser. No. 61/525,259 filed
Aug. 19, 2011 and PCT/US12/51512 application filed Aug. 18, 2012
under 35 U.S.C. .sctn.111(a) (hereby specifically incorporated
herein by reference).
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
[0002] None.
REFERENCE TO SEQUENCE LISTING, A TABLE FOR A COMPUTER PROGRAM
LISTING, COMPACT DISC APPENDIX
[0003] None.
FIELD OF THE INVENTION
[0004] The present invention relates to a fluoroscopic alignment
apparatus and system and method to use this apparatus in various
orthopedic applications, such as, an anterior total hip
arthroplasty.
BACKGROUND OF THE INVENTION
[0005] Many of the radiographic parameters essential to total hip
arthroplasty (THA) component performance, such as wear, and
stability, can be assessed intraoperatively with fluoroscopy.
However even with intraoperative fluoroscopic guidance, the
placement of an implant may still not be as close as desired by the
surgeon. For example, malpositioning of the acetabular component
during hip arthroplasty can lead to problems. For the acetabular
implant to be inserted in the proper position relative to the
pelvis during hip arthroplasty requires that the surgeon know the
position of the patient's pelvis during surgery. Unfortunately, the
position of the patient's pelvis varies widely during surgery and
from patient to patient.
[0006] Various devices have been suggested to reduce malpositioning
of these surgical components. For example, a transverse acetabular
ligament has been suggested as a qualitative marker of the
orientation of the acetabulum. (Archbold H A, et al., The
Transverse Acetabular Ligament; an Aid to Orientation of the
Acetabular Component During Primary Total Hip Replacement: a
Preliminary Study of 1000 Cases Investigating Postoperative
Stability, J Bone Joint Surg BR. 1906 July; 88(7):883-7. However,
it has been suggested that the acetabulum may be deteriorated due
to arthritis. Others have proposed using a tripod device that uses
the anatomy of the ipsilateral hemi pelvis as the guide to position
the prosthetic acetabular component. U.S. Patent Publication Number
19090306679. This instrument has three points. The first leg is
positioned in the area of the posterior inferior acetabulum, a
second leg is positioned in the area of the anterior superior iliac
spine and a third leg is positioned on the ileum of the subject.
U.S. Patent Publication Number 19090306679. However, a need exists
in the industry for a device that is not implantable or invasive
and is adaptable to a variety of applications.
SUMMARY OF THE INVENTION
[0007] A surgical positioning system is provided that includes a
radiolucent grid having a plurality of dimensioned radio-opaque
lines corresponding to surgical variables and a substrate connect
to or integral with the radiolucent grid. This system is used to
obtain subject specific data from an image of a subject obtained
during a surgical procedure by following the steps of: providing a
radiolucent grid having a plurality of dimensioned radio-opaque
lines relating to surgical variables; placing the subject on a
substrate; and obtaining subject specific data from an image of
said subject. This invention also provides an apparatus made of a
radiolucent grid having a plurality of dimensioned radio-opaque
lines relating to surgical variables and a sealable radiolucent
container sized to receive the grid. This embodiment simplifies the
sterilization, if required of the grid plate between surgical
applications.
[0008] In another embodiment, the substrate is an operating room
table mat and the grid is integrated into the operating room table
mat to form a dimensioned grid mat. The dimensioned grid mat has at
least one aperture in a top surface sized to accommodate a
positioning device. The positioning device is sized to project
through and above the top surface of the dimensioned grid mat,
wherein the position of a subject on the mat can be maintained in a
selected position with the at least one positioning device.
[0009] In another embodiment, the grid is not a complete table or
is not integrated into a complete table, but is an independent
extension which adapts to any operating room table and/or
integrates into, or adapts with, a mobile leg positioner.
[0010] In another embodiment, disposable sterile, or non-sterile,
fluoroscopic grid-drape for use intraoperatively, independent of,
within, or as an integral part of C-arm drape/sleeve/cover, to
determine angulation and alignment of implants and/or limbs is
provided.
[0011] In another embodiment, disposable sterile, or non-sterile,
fluoroscopic grid having the ability to attach to the C-arm image
intensifier by means of any method, such as magnets, suction
cups/devices/tapes, clamps, and straps is provided. This includes
method of grid attachment to the C-arm image intensifier or any
other plate/sleeve/apparatus using adhesives of any type.
[0012] In another embodiment, use of radiopaque ink methods and
technology to print a grid pattern for use in any musculoskeletal
surgical procedure are provided. The radiopaque ink printing can be
applied to any suitable and appropriate substrate.
[0013] All designs and embodiments include sterile/non-sterile, and
disposable/non-disposable applications.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING
[0014] The drawing shows schematically a fluoroscopic alignment
plate apparatus and method of use according to an example form of
the present invention. The invention description refers to the
accompanying drawings:
[0015] FIG. 1 is a perspective view of an embodiment of the
dimensioned grid plate of the present invention.
[0016] FIG. 2 is a front view of an embodiment of the dimensioned
grid plate apparatus of the present invention.
[0017] FIG. 3 is a side view of an embodiment of the dimensioned
grid plate apparatus of the present invention.
[0018] FIG. 4A is a side view of the apparatus of the present
invention.
[0019] FIG. 4B is a top view of the translational/rotational
mechanism of the present invention.
[0020] FIG. 5 is a rear view of an embodiment of the dimensioned
grid plate apparatus of the present invention.
[0021] FIG. 6A is an illustrative sketch showing the relationship
of the patient to the apparatus in an anterior approach.
[0022] FIG. 6B is an illustrative sketch showing the relationship
of the patient to the apparatus in a posterior approach.
[0023] FIG. 7 is a front view of another embodiment of the
dimensioned grid plate apparatus of the present invention.
[0024] FIG. 8 is a sketch of X-ray view showing hip anatomy with or
without implant and the grid overlay.
[0025] FIG. 9 is a schematic of an X-ray view of the hip anatomy
with implant grid overview.
[0026] FIG. 10 is a perspective view of the grid of the present
invention; and a view showing the pouch/bag/container.
[0027] FIG. 11A is a front perspective view of the apparatus of the
present invention used in a standard X-ray image technique where
the grid is placed on top of the patient and images taken as
needed.
[0028] FIG. 11B is a top view of the apparatus of the present
invention used in a standard X-ray image technique where the grid
is placed on top of the patient and images taken as needed.
[0029] FIG. 12 is an embodiment of the invention show a rear view
of an embodiment of the dimensioned grid plate apparatus of the
present invention.
[0030] FIG. 13A is an embodiment of the invention showing an
illustrative sketch showing the relationship of the patient to the
apparatus in an anterior approach.
[0031] FIG. 13B is an embodiment of the invention showing an
illustrative sketch.
[0032] FIG. 14 is a view of the apparatus of the present invention
used externally and integrated into the table mat/support
system.
[0033] FIG. 15 is a view of the apparatus of the present invention
integrated into the operating room table and patient positioning
system.
[0034] FIG. 16 is a top view of one embodiment of the grid
apparatus and the use of positioning devices to position the
subject.
[0035] FIG. 17A is an embodiment of the invention showing the
relationship of the grid and other associated intra-operative
tables and patient positioning equipment.
[0036] FIG. 17B is an embodiment of the invention showing the
relationship of the grid and other associated intra-operative
tables and patient positioning equipment.
[0037] FIG. 17C is an embodiment of the invention showing the
relationship of the grid and other associated intra-operative
tables and patient positioning equipment.
[0038] FIG. 18 is an embodiment of the invention showing a mobile
leg positioner relative to a grid.
[0039] FIG. 19 is an embodiment of the invention showing an example
of grid geometry pattern wherein the grid can be a single line, a
geometrical patter, number, letter or a complex pattern of multiple
lines and geometries.
DETAILED DESCRIPTION OF THE INVENTION
[0040] The present invention may be understood more readily by
reference to the following detailed description of the invention.
It is to be understood that this invention is not limited to the
specific devices, methods, conditions or parameters described
herein, and that the terminology used herein is for the purpose of
describing particular embodiments by way of example only and is not
intended to be limiting of the claimed invention. Also, as used in
the specification including the appended claims, the singular forms
"a," "an," and "the" include the plural, and reference to a
particular numerical value includes at least that particular value,
unless the context clearly dictates otherwise. Ranges may be
expressed herein as from "about" or "approximately" one particular
value and/or to "about" or "approximately" another particular
value. When such a range is expressed, another embodiment includes
from the one particular value and/or to the other particular value.
Similarly, when values are expressed as approximations, by use of
the antecedent "about," it will be understood that the particular
value forms another embodiment.
[0041] These and other aspects, features and advantages of the
invention will be understood with reference to the detailed
description herein, and will be realized by means of the various
elements and combinations particularly pointed out in the appended
claims. It is to be understood that both the foregoing general
description and the following detailed description of the invention
are exemplary and explanatory of preferred embodiments of the
inventions, and are not restrictive of the invention as claimed.
Unless defined otherwise, all technical and scientific terms used
herein have the same meaning as commonly understood by one of
ordinary skill in the art to which this invention belongs.
[0042] The present invention, provides an apparatus and method for
determining and measuring leg length, offset, and cup position
during arthroplasty surgery by using a radiolucent dimensioned grid
plate positioned under the patient in conjunction with X-ray to
measure surgical variables, such as, hip implant position to
determine the relative leg length and offset measurements for the
implant. Arthroplasty surgery includes, for example: hip (anterior
approach), hip (posterior approach), knee, ankle, elbow, and
shoulder. The present invention includes an embodiment for trauma
applications. Trauma surgery includes any and all bone
fractures.
[0043] Now referring to FIG. 1 a radiolucent dimensioned grid plate
1 is designed to be sufficiently large to ensure that the body part
in questions, such as the entire pelvis and proximal femurs (left
and right), is captured in a fluoro image. The radio-opaque grid
(any and all metals, ceramics, plastics, complex materials such as
carbon fiber) has a (1 cm) quantifiable pattern or indicator (other
quantifiable patterns, English) with each individual "block" having
a square geometry. These grid lines align parallel to each other in
two directions--vertical (cephalad/caudad) 14 and horizontal
(medial/lateral) 2. However, it should be understood that the
geometry of the grid lines can vary depending upon the surgical
procedure and surgical requirements. For example, FIG. 18 shows a
radiolucent dimensioned grid plate 1 with a complex design used for
both a hip and a trauma application. The design can also be as
simple as one (1) 40 degree line (for cup abduction angle) or one
horizontal line (for leg length).
[0044] Now referring to FIG. 2, a radiolucent dimensioned grid
plate 1 for hip arthroplasty is provided. The radiolucent
dimensioned grid plate 1 is "sandwiched" between support plates 4
that have an extended aspect 6 in the caudal direction, to form the
radiolucent dimensioned grid plate apparatus 19. This caudal aspect
has a cutout 5 that matches and mates with an operating room
table's peg for use in an anterior approach procedure. The outer
layer of the support plates 4 are joined together at the corners 15
by a solid metal piece that will also serve as the attachment place
for the clamps that will attach the a radiolucent dimensioned grid
plate apparatus 19 to the operating room table 72 or to the hip
positioning apparatus (not shown). For strength, support rods (not
shown) can be added to the caudal aspect.
[0045] In this radiolucent dimensioned grid plate 1, two grid lines
form a V and are angled at 45 degrees to the vertical and
horizontal. In this dimensioned grid plate 1, these two lines
represent a guide 3 for quantifying the abduction angle of an
acetabular cup used during an arthroplasty procedure. However, the
desired angle for the guide 3 relates to the type of implant. Metal
on metal implants use a 40 degree angle of abduction, while
polyethylene based articular surfaces use a 45 degree angle. The
left half side of the radiolucent dimensioned grid plate apparatus
19 is a mirror image of the right hand side. The radiolucent
dimensioned grid plate 1 can have the following radio opaque
markings (any and all methods of etching or marking): Two 45 degree
angled radio opaque guide lines 3; two elliptical etchings which
represent the proper version of the acetabular component 8 adjacent
and cephalad to the 45 degree lines with a distance of
approximately 19 cm from the apex of the two 45 degree lines
(correlates to average standardized measurements of human pelvis
between the radiolucent lines representing the quadrilateral
surface, the roof of the obturator foramen, and the fossa
acetabulae (the "teardrop")); numbers representing the vertical
lines with zero being the midline and the numbers counted off in
both medial and lateral directions from zero 10; letters of the
alphabet on both sides of the grid representing the horizontal
(x-axis) 9; and an image of an anatomical feature, such as a pelvis
outline. All these grid lines and markings guide the physician in
defining the orientation for insertion of the implants and
specifically determining and measuring leg length, offset, cup
placement, and femoral head center of rotation and mechanical axis
of lower limb.
[0046] The radiolucent dimensioned grid plate 1 can be enclosed on
either side in an epoxy resin that is both transparent and with a
plurality of support plates 4 to form the radiolucent dimensioned
grid plate apparatus 19. The epoxy creates a complete seal for the
metal to prevent corrosion and support cleanability of the
radiolucent dimensioned grid plate apparatus 19. Other
manufacturing processes known to those skilled in the art include:
laser etched: etched, then filled with radio-opaque marker in
etched negative areas, then sandwiched; molded: with metal on
support plates 4; using tungsten as the radio-opaque material for
use in grid lines and numbers; sandwich deposition: printing
process (like circuit boards); CNC Machined: back filled and
radio-opaque decal: use of radio-opaque ink placed on support
plates 4.
[0047] Now referring to FIGS. 3, 4A and 4B, a plurality of support
plates 4 is shown surrounding the dimensioned grid plate 1. This
central axis pin 11 is attached to the outer support plates 4 by
conventional means such as a screw threaded through the support
plate into the end of the central axis pin 11. The central axis pin
11 is captured on either end by a screw threaded through the
support plates 4 and into the end of the axis pin--on both ends. A
medial-lateral slot 13 allows a +/-5 cm medial-lateral translation
of the dimensioned grid plate 1 relative to the support plates 4.
The central axis pin 11 is oriented perpendicularly to the surface
of the plurality of support plates 4 and the central axis pin 11
projects upwardly. This dimensioned grid plate 1 has a slot 13. The
slot 13 allows the dimensioned grid plate 1 to be shifted from side
to side or medially-laterally.
[0048] Now referring to FIGS. 4A and 4B, the dimensioned grid plate
1 articulates within the support plates 4 by a central axis pin 11.
The medial-lateral slot 13 allows +/-5 cm medial-lateral
translation of the dimensioned grid plate 1 relative to the support
plates 4 and the patient 27. The radiolucent dimensioned grid plate
1 can also be rotated +/-40 degrees about the central axis pin 11
axis relative to the support plates 4 and the patient 27. The
radiolucent dimensioned grid plate 1 is rotated or translated by
using the handle 12 that is attached to the radiolucent dimensioned
grid plate apparatus 19. The radiolucent dimensioned grid plate 1
rotates about the central axis pin 11.
[0049] The slot 13 is configured with scalloped sides or edges that
allow the radiolucent dimensioned grid plate 1 to be indexed at a
plurality of positions. The central axis pin 11 has a central axis
pin groove 21 about which the radiolucent dimensioned grid plate 1
will rotate. The central axis pin groove 21 will further have a
series of countersunk grooves 22 for engagement of spring-loaded
ball 23 (for location of rotational position of the dimensioned
grid plate 1 relative to the outer support plates. Furthermore, the
radiolucent dimensioned grid plate 1 translates in a medial lateral
direction along the central axis pin 11. This translational
movement is achieved by utilizing countersunk grooves 26 with a
spring-loaded device (SLD) 24 having a uniform groove and
countersunk slot configuration. The indexing is accomplished by a
translation/rotational mechanism 25. The central axis pin 11 has
the ability to translate along the medial-lateral slot 13 and
engage in any one of a series of positions in the medial lateral
direction. This is accomplished by having a plurality of
spring-loaded device 25 used in conjunction with a plurality of
corresponding countersunk slots 26. This rotation is accomplished
by the configuration of the medial lateral slot 13.
[0050] The slot 13 is made of a plurality countersunk grooves 26
that are configured to retain the central axis pin 11.
Additionally, the surface opposite 30 one of the plurality of
countersunk grooves 26 is configured to retain a spring-loaded
device 24. A plurality of spring-loaded devices 24 mediate the
movement of the radiolucent dimensioned grid plate 1. The
spring-loaded device 25 releasably holds the central axis pin 11 in
the selected scalloped or notched position. The
engagement/disengagement position and force will be determined
based upon spring-loaded device holding capacity. The central axis
pin 11 can be fluted longitudinally 22 which allows a rotational
detent action as the patient (on the radiolucent dimensioned grid
plate apparatus 19) is rotated in the horizontal plane about the
central axis pin 11.
[0051] Now referring to FIG. 5, on the underside of the radiolucent
dimensioned grid plate apparatus 19 there are strips of an adhesive
material such as VELCRO (Velcro Industries B.V.) 17 to further
secure the plate to the operating room table 72. This prevents the
radiolucent dimensioned grid plate apparatus 19 from moving
relative to the operating room table or patient during the surgical
procedure. In another embodiment, the radiolucent dimensioned grid
plate apparatus 19 can include posts 18 to attach to an operating
room table 72. The dimensioned grid plate 1 does not need to be
secured and can be used in a "free-hand" technique where the
radiolucent dimensioned grid plate apparatus 19 is simply held in
position--this includes holding the radiolucent dimensioned grid
plate apparatus 19 above the patients pelvis or holding a
radiolucent dimensioned grid plate apparatus 19 up in front of the
fluoro image on the X-ray machine. It should be noted that the
radiolucent dimensioned grid plate apparatus 19 is disposable or
resterilizable.
[0052] Now referring to FIGS. 6A and 6B, this embodiment allows for
use in all surgical approaches to the hip. For the anterior
approach, the dimensioned grid plate apparatus 19 is used as shown
in FIG. 6A, the patient is in a supine position with the
radiolucent dimensioned grid plate apparatus 19 placed beneath the
patient's pelvis. For the posterior approach as shown in FIG. 6B.
The added benefit is having the ability to rotate, translate ML,
and ideally position the grid to the anatomy of the patient. The
dimensioned grid plate 1 has the ability to rotate +/-40 degrees
from the vertical and translate in the medial lateral direction
+/-5 cm. The radiolucent dimensioned grid plate 1 can translate
cephalad/caudad by adjusting the clamps which fix the radiolucent
dimensioned grid plate apparatus 19 to the bed or the hip
positioning device.
[0053] The dimensioned grid plate apparatus 19 can also be used for
an anterior approach procedure. The Hilgenreiner's line 31 is a
line drawn horizontally through the superior aspect of both
triradiate cartilages. It should be horizontal, but is mainly used
as a reference for Perkin's line and measurement of the acetabular
angle.
[0054] The radiolucent dimensioned grid plate apparatus 19 has an
extension in the caudad direction that has enough distance to allow
the grid to lock onto the operating room table 72 and then also
ensure that the radiolucent dimensioned grid plate apparatus 19 is
directly behind (posterior) the patient's 27 pelvis. The extension
piece has a slot or cut out 5 that matches the diameter of the peg
(not shown) on the operating room table 72 that is being used. The
peg (not shown) is fixed to the table and so by locking the peg to
the plate there will be no motion of the radiolucent dimensioned
grid plate apparatus 19 relative to the patient 27 during the
surgery. In testing that was performed, tables that are conducive
to the direct anterior approach were used. The radiolucent
dimensioned grid plate apparatus 19 and method can be used on any
radiolucent operating room table.
[0055] For a posterior surgical approach, FIG. 6B, the patient 27
is placed in the appropriate position for hip replacement surgery.
The surgeon places the patient 27 in a Lateral Decubitus position;
the surgeon positions the radiolucent dimensioned grid plate
apparatus 19 directly behind the pelvis of the patient 27. Once the
surgeon has the trial implants or final implants inserted in the
correct position inside the body, the surgeon will bring in the
mobile X-ray machine (C-arm) and align the C-arm beam with the
pelvis and grid plate in the anterior posterior plane. The image
generated by the C-arm will provide a fluoro view of the anterior
posterior pelvis and a grid pattern overlay. For the use in a
posterior surgical approach, the patient 27 can be placed on the
patient's 27 side in an appropriate and traditional manner. The
surgeon will examine the X-ray image to determine subject specific
data. Three parameters will be measured and determined at this
point: 1) leg length, 2) offset, and 3) cup position.
[0056] Leg length: In quantifying leg length discrepancy, the
patient's anatomical landmark(s) can be geometrically dimensioned
relative to the grid lines. For example, points on the grid line
drawn through the bottom of the ischium may be viewed as points on
the grid marked along the H grid line. The proximal aspect of the
left and right lesser trochanters may be viewed as points on the
grid marked as G3 and F3 respectively.
[0057] The distance measured counting or using the grid squares
between the ischial axis grid line and the respective two lesser
trochanter points (G3 and F3 for example) is the leg length
discrepancy. Alternatively, a surgeon's preference may be to use
points on the grid marking the greater trochanter in conjunction
with the grid lines through the obturator foramina.
[0058] Offset. The offset of the femoral component is the distance
from the center of rotation of the femoral head to a line bisecting
the long axis of the stem: In a similar technique to leg length,
offset can be quantified. Corresponding radiographic points
identified on the patient's left and right pelvis and proximal
femur can be measured with the grid lines and blocks. The
difference between the left and right measurements will quantify
the offset mismatch and provide the surgeon with a numerical number
to allow restoration of proper offset.
[0059] Pelvic Acetabular Implant commonly referred to as the "cup":
The optimal position of the acetabular component can be determined
using the radiolucent dimensioned grid plate apparatus 19 as an
alignment and measurement device. The radiolucent dimensioned grid
plate apparatus 19 has a 45 degree angled metal line 3. The
radiographic image will display the trial or final implanted
acetabular cup positioned in the acetabulum relative to the 45
degree guide line 3 that will be superimposed on the image. The cup
position can then be adjusted based upon image feedback until
correct positioning of the final implant is determined.
[0060] Now referring to FIGS. 7 and 8, a radiolucent dimensioned
grid plate apparatus 19 can be adapted for a variety of end-uses
such as to facilitate the placement of an implant in arthroplasty
or trauma procedure; for fracture reduction/correction during a
trauma procedure or for deformity correction planning. In
operation, the proximal femoral angle at 40 is determined. Next the
distal femoral angle is determined at 42 Next the proximal tibial
angle 46 is determined Next the distal tibial angle 43 is
determined to form the "X" axis relative to the "Y" axis 35 of the
dimensioned grid plate apparatus 19.
[0061] The Y axis 35 is the center line that creates a mirror image
of grid and reference lines on either side of it, thus allowing use
for either a left or a right leg application 49 marks the center of
the femoral head location. The proximal pelvic section of the
device also has two 45 degree lines that intersect at the center of
the femoral head point 49. These same lines can also be used to
quantify femoral neck angle 51. The knee section 48 is made of a
grid pattern matching that of radiolucent dimensioned grid plate
apparatus 19. Similarly, the ankle section 47 is made of a grid
pattern matching that of radiolucent dimensioned grid plate
apparatus 19. The knee section has a central x-axis 42. Similarly,
the ankle section 47 has central x-axis 43. The knee grid section
48 has two 3 degree lines 46 for use in quantifying alignment as
needed.
[0062] In another embodiment, and now referring to FIG. 8, a
radiolucent dimensioned grid plate apparatus 19 for use with a
trauma procedure on a lower extremity is disclosed. The trauma
implications go beyond the pelvis and acetabulum. A larger
radiolucent dimensioned grid plate apparatus 19 that runs from the
patient's pelvis to beyond the ankle allows a surgeon to confirm
length using the contralateral side. Additionally, the radiolucent
dimensioned grid plate apparatus 19 allows the surgeon to confirm
alignment prior to and after placement of an implant. The y-axis 35
correlates with the mechanical axis that runs from the head of the
femur through bony landmarks in the tibial plateau through to the
distal tibia. Angles that may create the x-axis 40 (depending upon
fracture location) could be: proximal femoral angle; lateral distal
femoral angle; medial proximal tibial angle; distal tibial
angle.
[0063] Now referring to FIG. 9, an X-ray view of hip anatomy within
implant and grid overview is shown. In quantifying leg length
discrepancy, the patient's anatomical landmark(s) can be
geometrically dimensioned relative to the grid lines. For example,
points on the grid line drawn through the bottom of the ischium may
be viewed as points on the grid marked along the H grid line 91.
For example, the proximal aspect of the left lesser trochanters of
the affected hip may be viewed as a point on the grid marked as
G6.5 93 on the unaffected hip it can be determined that this same
point is G5.5. For example, the distance measured counting or using
the grid squares between the ischial axis grid line H 91 and the
respective two lesser trochanter points (G6.5 and G5.5 for example)
is the leg length discrepancy, relating to the inserted cup 90.
[0064] In another embodiment, deformity correction works much the
same as the trauma description above. An existing deformity is
evaluated against the patient's contralateral side. The radiolucent
dimensioned grid plate apparatus 19 is used to ensure that the bone
length and alignment correlate to the contralateral side. The
radiolucent dimensioned grid plate apparatus 19 allows the surgeon
to evaluate whether the osteotomy is sufficient to correct
alignment and/or length intraoperatively, as well as making it
visually easier to plan a correction procedure by using the grid to
obtain pre-operative radiographs (i.e., surgeon does not have to
draw his own lines and angles on plain radiographs to try to
determine the appropriate amount of bone to remove and/or cut and
re-angle).
[0065] Now referring to FIGS. 10, 11A, and 11B, a radiolucent grid
100 is shown. The radiolucent grid 100 has a plurality of
dimensioned radio-opaque lines relating to surgical variables. The
portion of the grid that is not opaque is radiolucent. The
radiolucent grid 100 can be referred to as a radiolucent grid
having a plurality of dimensioned radio-opaque lines. The
radiolucent grid 100 can include any shape or pattern of geometric
nature or text to reference angles, length positioning or
targeting. The radiolucent grid 100 is formed of a material that
can be sterilized, if desired, such as plastic or carbon fibers.
The radiolucent grid 100, in one embodiment, can be placed in a
sealable container 104, such as a bag or pouch that can be allowed
to be used in a sterile field. This step can occur within a sterile
environment during any surgical procedure. For example, the
radiolucent grid 100 is placed inside a sterile pouch, bag, or
container 104. The sterile pouch, bag, or container 104 can be
manufactured of any suitable material. A standard X-ray container
can be sealed with the radiolucent grid 100 in sterile pouch, bag
104 within.
[0066] The same protocol can be followed in a non-sterile
environment before, during, and/or after any surgical event. The
combination of the radiolucent grid 100 within a sterile pouch,
bag, or container 104 is referred to as the grid plate assembly
106. The radiolucent dimensioned grid plate assembly 106, in one
embodiment, is positioned on top of a patient 27. The surgeon can
move the radiolucent dimensioned grid plate assembly 106 as
fluoroscopic images are taken. The radiolucent dimensioned grid
plate assembly 106 can be adjusted intraoperatively.
[0067] Now referring to FIG. 12, disposable sterile, or
non-sterile, fluoroscopic grid-drape for use intraoperatively,
independent of, within, or as an integral part of C-arm
drape/sleeve/cover, to determine angulation and alignment of
implants and/or limbs is disclosed. This embodiment to include uses
for any and all musculoskeletal surgical procedures (to include:
hip replacement, knee replacement, shoulder replacement, trauma
fracture repair, etc.) All embodiments include any use of the
radiolucent grid 100 as a disposable item.
[0068] More specifically, in a sterile environment during any
surgical procedure, a radiolucent grid 100 is incorporated into a
sterile disposable C-arm sleeve, pouch, bag, cover, or container
104. The sterile sleeve, pouch, bag, cover, or container 104 can be
manufactured of any suitable material, such as high density
polyethylene or low density polyethylene. The sleeve, pouch, bag,
container 104 can be sealed with the radiolucent grid 100 enclosed
within to form a radiolucent grid assembly 106. The radiolucent
grid assembly 106 can be integrated into the sleeve, pouch, bag,
cover, or container 104 and placed over the C-arm image intensifier
162 in a standard sterile manner in preparation for C-arm use. The
same protocol can be followed in a non-sterile environment before,
during, and/or after any surgical event.
[0069] Now referring to FIGS. 13A and 13B: disposable, or
non-disposable sterile, or non-sterile, radiolucent grid 100 for
use as an attachment to the C-arm image intensifier 162 (or any
X-ray receiver) or the tube 171 is shown. The radiolucent grid 100
is attached with the use of magnets (standard or Niobium) suction
cup technology (standard, Gecko, Nano suction technology) 173, or
any other means such as straps or clamps, and adhesives (glue,
tape) or manually holding the radiolucent grid 100 in place against
either the X-ray image intensifier/receiver or the X-ray tube. The
radiolucent grid 100 having a plurality of dimensioned radio-opaque
lines relating to surgical variables is placed in a sealable
radiolucent container sized to receive the radiolucent grid 100 to
form a radiolucent grid assembly 106; and the radiolucent grid
assembly 106 is positioned over the C arm intensifier 162 of an
X-ray machine.
[0070] Now referring to FIG. 14, a surgical positioning system made
of: a radiolucent grid 100 having a plurality of dimensioned
radio-opaque lines corresponding to surgical variables and a
substrate 127 connect to or integral with the radiolucent grid 100
is shown. The substrate 127 can be for example an operating room
table mat, operating room table, a mobile positioning device and a
surgical drape. There is a central post 135 of the operating table.
In one embodiment, the radiolucent grid 100 is integrated into
and/or manufactured within the operating room table mat or cover to
from a dimensioned grid mat 122. The radiolucent grid 100 can be
attached to a substrate, such as an operating room table 127 or a
moving table 170.
[0071] The dimensioned grid mat 122 is manufactured of foam or any
operating room table material that adheres to patient comfort and
safety standards. The dimensioned grid mat 122 may be fixed or
connected to the substrate such as operating room table 127, by any
method and device to ensure secure fastening and locking of the
dimensioned grid mat 122 to the operating room table 127. This may
include straps, VELCRO (Velcro Industries B.V.) screws, tie-downs,
clamps, and any other fixation or holding jig. Further, this
dimensioned grid mat 122 includes any and all geometries of
operating room table designs. The dimensioned grid mat 122 may be
perforated with a plurality of apertures 123 in any pattern that is
conducive to allow positioning of the patient by using positioning
devices 124 of any geometry. In this embodiment, at least one
aperture 123 in the grid 122 is sized to receive or accommodate a
positioning device 124. The positioning device 124 projects above
the top surface 128 of the mat and is configured to maintain the
position of the subject relative to the radiolucent grid 100 or
grid mat 122. There is a central post 135 of the operating
table
[0072] The plurality of positioning devices 124 can be used to
facilitate the positioning of the radiolucent grid 100 relative to
the patient 27. The positioning device 124 are rods or tubes that
allow for appropriately positioning and holding the patient 27
securely to allow for accurate imaging and visualization of the
patient 27 anatomy relative to the operating room table 127 and
dimensioned grid mat 122.
[0073] The positioning device 124 can be added to an aperture 123
configured to receive the positioning device 124 or in an
alternative embodiment the aperture 123 is configured to
accommodate the positioning device 124 and the positioning device
124 is attached to the grid and telescopes out of the aperture
123.
[0074] Now referring to FIG. 15, the radiolucent grid 100 has a
plurality of dimensioned radio-opaque lines integrated into and/or
manufactured within the operating room table 127. In this
embodiment, the dimensioned grid mat 122 is connected to the
operating room table 127 surface by positioning device 124 that can
be manufactured with and include any and all suitable materials. In
this embodiment, the operating room table 127 is manufactured of
any operating room table material that adheres to safety standards.
The dimensioned grid mat 122 is integrated into the operating room
table 127 to form a grid-table assembly 140. In addition, the
grid-table assembly 140 may be perforated in any pattern that is
conducive to allow appropriate positioning of the patient 27 by
using positioning devices of any geometry. The operating room table
127 with integrated radiolucent grid 100 and positioning device can
be manufactured with and include any and all suitable
materials.
[0075] As shown in FIG. 16, the patient 27 is placed on the
dimensioned grid mat 122. The positioning devices 124 are
strategically placed at selected locations alongside the patient's
27 body areas according to patient's 27 anatomy and then secured in
position within the perforations 123. The plurality of positioning
devices 124 can be secured to either the radiolucent grid 100 with
a depression in the grid surface or by the use of a clamp or
rail.
[0076] Now referring to FIGS. 17A-C, further, this grid-table
assembly 140 includes any and all geometries of operating room
table designs. In this embodiment, a plurality of pegs 145 can be
used to facilitate a pelvic tilt or elevated mat 147 that can be
used for an anterior approach in order to maintain the correct
pelvic orientation. Further, the grid-table assembly 140 can be
integrated into the design of the central peg of the operating room
table 127 or any extension of the operating room table used for an
anterior or posterior hip approach or trauma procedure. For
example, an internal positioning peg 145 can be used for adapting
the basic design for other types of surgery. The peg 145 is formed
of upwardly projecting member on a base and is made of a suitable
material such as plastic. The material must not be deformable.
[0077] In another embodiment, a plurality of pegs 145 can be used
to prevent a pelvic collapse during surgery and to maintain pelvic
area centered on the operating room table 127, while non-supported
parts allow for collapse to help with the stability and comfort.
The plurality of pegs 145 can be adjusted to accommodate width and
the height of a patient's pelvis. A plurality of pegs 145 can be
used to position a flap 147 configures to form a raised area that
can stabilize or immobilize a body part during surgery.
[0078] Now referring to FIG. 18 the radiolucent grid 100 may not be
a complete table or is not integrated into a complete table, but is
an independent extension which adapts to any operating room table
127 and/or integrates into, or adapts with, a mobile leg positioner
170 for use in anterior or posterior hip replacement surgery. In
this embodiment, a central post apparatus 155 is attached to the
operating room table 127 top and can be used to accommodate
supplemental extensions and external apparatus with leg holding and
moving functions, namely a mobile leg positioner 170. The central
post apparatus 155 is part of the mobile leg positioner 170 and is
part of the mobile leg positioner 170. The central post apparatus
155 has a cylindrical geometry strategically placed between the
patient's 27 legs to support the subject during surgery. The leg
holder 156 is configured to hold the leg during surgery. The mobile
leg positioner 170 is made of a frame 173 to which a plurality of
wheels 171 are attached and can structurally have any design
configuration that function as an adjunct, mobile, add-on,
accessory, to an existing surgical table.
[0079] Now referring to FIG. 19, is an embodiment of the invention
showing an example of grid geometry pattern wherein the
radio-opaque portion of the grid can be a single line, a
geometrical patter, number, letter or a complex pattern of multiple
lines and geometries that correspond to surgical variables. The
grid patterns are predesigned based upon the surgeons knowledge of
anatomy and clinical experience including interpretation of
morphometric literature and studies identifying key relationships
and dimensions between anatomical landmarks and its application in
supporting good surgical technique as it relates to specific
procedures.
[0080] Use of radiopaque ink methods (pad, sheet printing) and
technology (medical inks, metal inks, tungsten inks), or templating
and stenciling methods, to print a grid pattern with surgical
variables for use in any musculoskeletal surgical
procedure-particularly, hip replacement, shoulder replacement, knee
replacement, and all bone fracture reductions for example a tibial
plateau fracture is shown. The radiopaque ink printing is applied
to any suitable and appropriate substrate such as acrylic,
polycarbonate, polypropylene, or polyethylene materials.
[0081] Clinical Study Example: This retrospective cohort study
reviews postoperative radiographic findings of 160 consecutive
primary total hip athroplasties performed through an anterior
supine approach with the aid of intraoperative fluoroscopy. The
control group was 100 total hip athroplasties performed without the
radiolucent dimensioned grid plate apparatus 19. The study group
was 54 total hip athroplasties performed with the use of the
radiolucent dimensioned grid plate apparatus 19 to aid in assessing
acetabular component inclination, femoral offset, and leg length.
Femoral offset, component abduction and leg length differences were
measured by two readers blinded to the group status. Surgeon aims
included an inclination angle of 40-45 degrees and a leg length and
offset equal to the contralateral side. Additionally, the two
groups were assessed for differences in demographics and clinical
outcomes including complications such as dislocation and
symptomatic leg length discrepancy.
[0082] Results: Inclination angle averaged 42 degrees (SD 1.5
degrees) for the grid group compared to 45 degrees (SD 4 degrees).
Femoral offset averaged +1.5 mm (SD 1 mm) compared to the
contralateral side for the grid group compared to -1 mm (SD 3 mm)
for the control group. Leg length differences averaged +1.5 mm (SD
1 mm) compared to the contralateral side for the grid group
compared to -1 mm (SD 3 mm) for the control group.
[0083] There were no statistically significant differences in age,
gender, BMI or dislocation rate between groups. However, the group
using the dimensioned grid plate apparatus 19 had a lower rate of
symptomatic leg length discrepancy than the control group.
[0084] Conclusions. While intra-operative use of fluoroscopy to
guide femoral offset, leg length and acetabular inclination is
helpful, a radiopaque guide with abduction angle references can be
helpful to improve precision and accuracy in accomplishing the
orthopedic surgeon's goals.
[0085] While the invention has been described with reference to
preferred and example embodiments, it will be understood by those
skilled in the art that a variety of modifications, additions and
deletions are within the scope of the invention, as defined by the
following claims.
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